The popular herbal treatment Echinacea should not be given any longer to children under 12 years of age because of possible adverse reactions, according to an advisory issued by the Irish Medicines Board (IMB).
Groups supporting the use of herbal remedies have criticised the move claiming there was no scientific data identifying any health risks.
Echinacea is a widely used flower-based herbal remedy said to reduce the incidence of common colds and diminish their severity.
The latest safety evaluations led the board to conclude however that use of Echinacea could be associated with "rare side effects, mainly allergic reactions which in some cases may be severe".
"This is not a serious safety issue and the measures being taken are precautionary in nature," said Ms Ann O'Connor, the board's director of human products authorisation. It was a "prudent measure" based on a scientific evaluation, she added.
The Irish Association of Health Stores was critical of the decision and demanded to know the evidence on which it was made. Products containing Echinacea had been used by children in Ireland for almost 20 years, over which time there was "no knowledge of any adverse event", the association said.
There was "no up-to-date evidence" to show the product was unsafe for use by under 12s, said Ms Jill Bell, the president of the Association. "This ban by the IMB is completely unjustified and will cause worry to many parents who want to protect their children's health," she said.
Blocking its use in young children would increase infection rates and encourage more use of antibiotics. "There might be more sense in banning the sale of peanuts," she said.
"Echinacea would be a massive medicine for herbalists," said Susie Quigley, general secretary of the Irish Registry of Herbalists. "We would view it as a safe herb."
The board said the recommendation was "based on the lack of scientific data" to support the product's use in children under 12, saying there was "limited evidence of benefit in this age group".
It has begun telling retailers and others involved in supplying the children's product to remove it from sale. Product information when it describes dosages for under 12s should also be changed over time. Adult Echinacea herbal products are not affected by the advisory.
The board's decision to look at safety issues related to the product arise because of Ireland's implementation in 2011 of the European Herbal Medicines Directive. This triggered a review of previously unregulated herbal products being sold on the Irish market.
Its decision was also guided by advice provided by the Committee on Herbal Medicinal Products of the European Medicines Agency.
